PET Adapted Treatment of Patients With Limited Stage DLBCL and no Risk Factors

Lymphoma, Non-Hodgkin's, Adult Clinical Trial

Official title:

Treatment of Patients With Diffuse Large B-cell Non-Hodgkins Lymphoma in Stages I and II Without Risk Factors, Adapted to the Response Evaluated With PET CT (Positron Emission Computed Tomography)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078840
• Other study ID #: GATLA 10-LNHDCG-20
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: January 2024
• Source: Grupo Argentino de Tratamiento de la Leucemia Aguda
• Contact: Astrid Pavlovsky, Dr.
• Phone: 5491150613683
• Email: astridp[@]intramed.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Prospective, multicenter, phase IV study, of real-life evidence destined to evaluate the feasibility and efficacy of performing a treatment adapted to PET-CT in patients with stage I and II DLBCL, without poor prognostic factors.

Description:

Patients older than 17 years of age, with no upper age limit with a de novo histological diagnosis of DLBCL, in stages I and II and without risk factors, will be included. All patients will have a baseline PET-CT and will undergo 3 cycles of R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). A PET-CT will be performed on day 15-18 of the third cycle that will be centrally reviewed. Those patients with negative PET-CT (Deauville 1, 2 and 3) will receive an additional cycle of R-CHOP and will finish treatment. Patients who have PET-CT with a Deauville 4 score will complete a fourth cycle and then receive radiation therapy to the compromised site. Those patients with a Deauville score of 5 should receive rescue therapy, so they will be outside the protocol.

A standardized follow-up of the patients included with tomographic controls will be carried out, evaluating OS (overall survival) and PFS (progression-free survival) at 3 years as the main objectives.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Patients > 17 years old with no upper age limit.

• Histological diagnosis of DLBCL Stages I or II

• Patients who have signed informed consent.

Exclusion Criteria:

• Patients with elevated LDH (lactate dehydrogenase)

• ECOG (Eastern Cooperative Oncology Group) > 2

• Stage III or IV

• Bulky mass (> 7.5 cm)

• Central nervous system involvement

• Testicular lymphoma

• Breast involvement

• Eyeball involvement

• Primary mediastinal lymphoma

• Cutaneous primary lymphoma

• Diffuse large B-cell lymphoma of the leg

• HIV positive patients

• Platelet count <100,000 / mcl and total leukocyte count <3,000 / mcl

• Marked impairment of ventricular function (FEy <50%)

• Moderate / severe renal impairment defined by Cl. Cr. <50 ml / min

• Severe liver disease: prothrombin rate <50% and / or bile level. total> 2.5 times normal value

• Pregnant and breastfeeding

• Previous or concomitant diagnosis of indolent lymphoma

• Patients who have previously received chemotherapy and / or radiotherapy

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Lymphoma, Non-Hodgkin's, Adult

Intervention

Other:
• Evaluation of first line treatment in patients with stage I and II LBCL
Evaluation of first line treatment in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP

Locations

Country	Name	City	State
Argentina	FUNDALEU	Caba
Argentina	Hospital Italiano de Buenos Aires	Caba
Argentina	Clínica Universitaria Reina Fabiola	Córdoba
Argentina	Hospital Privado de Córdoba	Córdoba
Argentina	Hospital Italiano de La Plata	La Plata	Provincia De Buenos Aires
Argentina	Instituto Privado de Hematologia y Hemoterapia	Paraná	Entre Ríos
Argentina	IDHEA Clínica Hematológica	Rosario	Santa Fe

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Argentino de Tratamiento de la Leucemia Aguda

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate PFS in patients with stage I and II LBCL (large B cell lymphoma), without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP.		36 months
Primary	Evaluate OS in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP		36 months
Secondary	Evaluate PFS in patients with negative PET after 3rd cycle who shortened treatment to only 4 cycles of R-CHOP.		36 months
Secondary	Evaluate PFS in patients with positive PET after 3rd cycle who continue treatment with R-CHOP x 1 and Radiotherapy.		36 months
Secondary	Evaluate the prognostic value of baseline MTV (metabolic tumor volume) in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP		36 months
Secondary	Evaluate the prognostic value of baseline TLG (total lesion glycolysis) in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP		36 months
Secondary	Evaluate the prognostic value of ? SUV (standardized uptake value) max in interim PET in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP		36 months
Secondary	Compare our results in terms of OS and PFS with those described in patients treated with R-CHOP x6		36 months
Secondary	Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi (interim PET) with R-CHOP x 4 (4 cycles of CHOP)		36 months
Secondary	Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi with R-CHOPx4+ 2 Rituximab or R-CHOPx 4 + ISRT (involved site radiation therapy) + Zevalin		36 months
Secondary	Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi with R-CHOPx 4 + RTCC + Zevalin		36 months